Clinical Data for Platinib

Pralsetinib (Pralsetinib) is a targeted therapy indicated for the treatment of metastatic rearrangements in adult patients with transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) diagnosed with a U.S. Food and Drug Administration (FDA)-approved test.

The U.S. Food and Drug Administration's (FDA) approval ofplatinib comes from the results of a Phase 1/2 open-label, non-randomized, multicenter, multi-cohort clinical trial called ARROW. Next-generation sequencing (NGS), fluorescence in situ hybridization (FISH), and other tests detect RET gene fusions.

A total of114 patients were enrolled in two independent cohorts. One cohort included 87 patients with metastatic RET fusion-positive NSCLC whose cancer progressed on platinum-based chemotherapy, while the other cohort included 27 patients with previously untreated metastatic NSCLC. The primary objectives of the study were overall response rate (ORR) and duration of response (DOR). Enrolled patients received 400 mg of platinib once daily until disease progression or unacceptable toxicity.

The cohort previously treated for NSCLC showedthe ORR was 57%, and the median duration of response was not estimable. 5.7% of patients showed a complete response, while 52% showed a partial response to the treatment. A total of 80% of patients demonstrated DOR of 6 months or longer. In another group of patients with previously untreated metastatic NSCLC, the ORR was 70%. 11% of patients showed a complete response to treatment, while 59% showed a partial response to treatment. The median DOR was 9 months, and 58% of patients showed a DOR of at least 6 months.

Common side effects of platinib observed in patients include constipation, muscle pain and fatigue, hypertension, neutrophil and lymphopenia, hemoglobin decrease, phosphate decrease, calcium decrease, sodium decrease, and alanine aminotransferase (ALT) increase.